Modafinil for ADHD May Be Another Alternative to Stimulants: Child and Adolescent Psychiatry

Randall F. White, MD, FRCPC; Andro Giorgadze, MD


August 07, 2006

A Randomized, Double-Blind, Placebo- Controlled Study of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit Hyperactivity Disorder

Greenhill LL, Biederman J, Boellner SW, et al

J American Acad Child Adolesc Psychiatry . 2006;45:503-511

Previous research has supported the effectiveness of modafinil in treating children with ADHD. These investigators used a smaller and more easily swallowed tablet than the one now on the market. They enrolled 200 patients, 73% boys and mean age 9.9 years, 131 of whom received modafinil; the rest received placebo. The medication, given once each morning, ranged in dose from 170 mg to 425 mg. The primary outcome measurement was the ADHD-RS-IV administered to teachers (School Version) and parents (Home Version) by researchers blind to treatment condition. They monitored adverse effects by nonspecific inquiry and spontaneous report, and obtained baseline and follow-up blood count, EKG, chemistries, vital signs, height, and weight.

Mean treatment duration was 31.5 days for modafinil and 36.4 days for placebo. Discontinuation for adverse effects occurred in 5% of the modafinil group and 6% of the placebo group. The adverse effects that occurred significantly more often in the modafinil-treated patients included insomnia, headache, and decreased appetite. Decreased appetite resolved in 61% of cases during treatment, but the children taking modafinil lost a mean of 0.6 kg while the children on placebo gained a mean of 1.3 kg ( P < .0001).

The mean scores on the ADHD-DS-IV School Version of the modafinil group began improving compared with the placebo group after 1 week of treatment but reached significance at the end of week 5. The mean scores on the ADHD-DS-IV Home Version diverged after 1 week, and the difference was significant in that and each subsequent week until the ninth, when the study ended. The effect size was 0.63 for teacher ratings and 0.78 for parent ratings.

This well-designed, short-term study of modafinil confirms its promise as a treatment for ADHD in children. Modafinil, now in use for treating hypersomnia in adults, shows efficacy in inattention and hyperactivity and is well tolerated. It does not, however, seem to be an alternative to stimulants that are devoid of their most troublesome side effects, including insomnia and appetite suppression, even with a once-daily morning dose. The long-term tolerability is an important question that a 1-year, open-label extension of this study, which is underway, will help answer.

Abstract (PubMed) URL:


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